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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91975

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 05, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smiths Medical ASD Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

Z-1580-2023
Recall number
Z-1580-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
47007 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

Code information

Lot Numbers: 3577218, 3738865, 3887812, 4024574, 4151070, 4258733, 3582650, 3752126, 3901443, 4029610, 4153964, 4258734, 3587542, 3761923, 3911867, 4038968, 4164878, 4264897, 3596826, 3768558, 3914813, 4041942, 4173946, 4269655, 3604794, 3768559, 3917564, 4063257, 4176082, 4279829, 3613310, 3772121, 3931273, 4063258, 4182389, 4279830, 3623879, 3779557, 3933681, 4067165, 4187590, 4284606, 3627084, 3784957, 3936715, 4072088, 4192791, 4284607, 3643070, 3788286, 3942733, 4076804, 4201183, 4290269, 3671340, 3798095, 3952706, 4081672, 4204667, 4290270, 3671341, 3802450, 3956054, 4086259, 4215512, 4318561, 3673809, 3805780, 3959458, 4090323, 4219068, 4335149, 3687267, 3819513, 3970976, 4093610, 4229475, 4335150, 3690140, 3828396, 3974773, 4104647, 4242508, 4337436, 3700821, 3836009, 3988375, 4108513, 4242509, 4361916, 3709028, 3849849, 4001786, 4111190, 4247925, 3712265, 3863155, 4005980, 4116119, 4247926, 3723465, 3867378, 4011955, 4132044, 4254339, 3735446, 3880821, 4018725, 4138935, 4258732

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.

device · product 2 of 3

DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

Z-1581-2023
Recall number
Z-1581-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
2101 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

Code information

3569291, 3802463, 3974741, 4093611, 4219069, 4340640, 3582651, 3832622, 4001787, 4108514, 4242510, 4340642, 3609721, 3871182, 4011956, 4116120, 4254340, 3609743, 3891814, 4032896, 4122394, 4264898, 3693349, 3914797, 4041943, 4151071, 4279831, 3723464, 3927549, 4063256, 4167796, 4290272, 3761125, 3952707, 4090324, 4182390, 4340638

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.

device · product 3 of 3

DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits

Z-1582-2023
Recall number
Z-1582-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
14941 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

Code information

Lot Numbers: 3572938, 3709023, 3917565, 4081673, 4176083, 4258736, 3582668, 3735447, 3936716, 4090325, 4176084, 4272705, 3602084, 3784974, 3974795, 4100952, 4187591, 4272706, 3617047, 3812333, 4011957, 4104648, 4207974, 4284609, 3623883, 3828394, 4029611, 4119019, 4207975, 4290273, 3631678, 3836006, 4038969, 4138936, 4220676, 4333910, 3662331, 3874536, 4063254, 4148601, 4242511, 4340649, 3688907, 3884430, 4067164, 4160298, 4254341, 4348704, 3693346, 3904854, 4076803, 4167797, 4258735

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.